Treatment with anti-ErbB2 antibodies

Abstract

The present invention concerns the treatment of disorders characterized by the overexpression of ErbB2. More specifically, the invention concerns the treatment of human patients susceptible to or diagnosed with cancer overexpressing ErbB2 with a combination of an anti-ErbB2 antibody and a chemotherapeutic agent other than an anthracycline, e.g. doxorubicin or epirubicin. The invention further provides a method of treating cancer in a human patient comprising administering effective amounts of an anti-ErbB2 antibody and a cardioprotectant to the patient.

What is claimed is: 
     
       1. A method for the treatment of a human patient with breast cancer characterized by overexpression of ErbB2 receptor, comprising administering a combination of an anti-ErbB2 antibody and gemcitabine, in the absence of an anthracycline derivative, to the human patient, wherein the combination is administered in an amount to increase time to disease progression compared to therapy with gemcitabine alone, and wherein said antibody binds epitope 4D5 within the ErbB2 extracellular domain sequence. 
     
     
       2. The method of  claim 1  wherein said breast cancer is metastatic breast carcinoma. 
     
     
       3. The method of  claim 1  wherein said antibody is a humanized 4D5 anti-ErbB2 antibody. 
     
     
       4. The method of  claim 1  wherein efficacy is measured by determining time to disease progression or response rate. 
     
     
       5. The method of  claim 1  wherein the antibody is not conjugated with the gemcitabine. 
     
     
       6. A method for the treatment of a human patient with an ErbB2 overexpressing breast cancer, comprising administering a combination of humanized anti-ErbB2 antibody that binds epitope 4D5 within the ErbB2 extracellular domain sequence and gemcitabine, to the human patient in an amount effective to treat cancer and to increase time to disease progression compared to therapy with gemcitabine alone. 
     
     
       7. A method for augmenting the chemotherapeutic effect of gemcitabine in a human patient with an ErbB2 overexpressing breast cancer as assessed by time to disease progression comprising administering to the patient a humanized anti-ErbB2 antibody that binds to epitope 4D5 within the ErbB2 extracellular domain sequence and gemcitabine, where the anti-ErbB2 antibody and the gemcitabine are each administered in amounts effective to increase time to disease progression.